ABSTRACT
The main objective of this book is to consider and compare the principle requirements of Good Manufacturing Practice (GMP), most notably in:
The US Current Good Manufacturing Practice for Finished Pharmaceuticals regulations (the “US cGMPs”)
The Guide to Good Manufacturing Practice for Medicinal Products of the European Union (the “EC GMP Guide”)
This book will also discuss the rationale behind these requirements and will propose ways and means of complying with them.
